A Multicentre Randomised Controlled Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy in Reducing Urinary Tract Infection (APPEAL): Statistical Analysis Plan and Methodology
Bibliographic record
Abstract
Abstract Background Urinary tract infection (UTI) is a recognized complication of shock wave lithotripsy (SWL) for urolithiasis. Evidence guiding antibiotic prophylaxis remains of low certainty, contributing to substantial practice variation and conflicting guidelines. A well-powered, blinded randomized trial is essential to provide trustworthy evidence for clinical practice. Study Design An international, multicentre, randomized controlled trial (the APPEAL trial) assessing the benefits and harms of a single dose of ciprofloxacin versus placebo before SWL in reducing post-procedure UTI. Patients, healthcare providers, data collectors, outcome adjudicators and statisticians blinded to treatment assignment. Endpoints Appeal’s primary outcome is bacteriuria or symptomatic UTI (symptomatic UTI defined as symptomatic cystitis, pyelonephritis, or urosepsis) within approximately 7-14 days post-SWL. Other outcomes include pyelonephritis or urosepsis, and serious adverse events. Patients and Methods Over 1,500 patients from high- and middle-income countries undergoing SWL for nephrolithiasis or ureterolithiasis. Exclusion criteria include a positive pre-SWL urine analysis for nitrites or urine culture, ongoing or planned antibiotic use, suspected struvite stones, urinary catheters or diversion, or a history of urosepsis. Imminent report of APPEAL will provide high-quality evidence on the role of antibiotic prophylaxis in SWL and identify subgroups that may benefit most. Trial Registration ClinicalTrial.gov identifier (ID): NCT03692715 .
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.111 | 0.124 |
| Meta-epidemiology (narrow) | 0.004 | 0.001 |
| Meta-epidemiology (broad) | 0.009 | 0.012 |
| Bibliometrics | 0.003 | 0.002 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.005 | 0.003 |
| Insufficient payload (model declined to judge) | 0.012 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".